soap products containing triclosanThe U.S. Food and Drug Administration Friday issued a final rule that will ban many commonly used consumer antiseptic soaps.

Companies will no longer be able to market antibacterial wash products with any of 19 specific active ingredients because manufacturers have not demonstrated the safety of long-term daily use or show that they are any more effective than plain soap and water in preventing illness or the spread of infections.

Some manufacturers, like Johnson and Johnson, have already started removing these ingredients from their products and, in May 2014, Minnesota became the first state in the US to ban the germ-killer triclosan from antibacterial soaps, toothpastes, body washes and other cosmetics. Wal-Mart and Procter & Gamble began phasing-out the chemical, which is a known endocrine disruptor, in products they sold in 2013.

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This final rule applies to consumer antiseptic wash products only, and allows the hand “sanitizers” in health care settings.

“Some data suggests that antibacterial ingredients may do more harm than good over the long-term,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

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The agency issued a proposed rule in 2013 after scientific studies suggested that long-term exposure to the active ingredients — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects. Manufacturers were required to provide the agency with additional data on the safety and effectiveness of the 19 active ingredients addressed in the rulemaking if they wanted to continue marketing the products.

Washing with plain soap and running water remains the most effective way to avoid getting sick and to prevent spreading germs to others. If soap and water are not available, the U.S. Centers for Disease Control and Prevention recommends that an alcohol-based hand sanitizer be used that contains at least 60 percent alcohol.

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In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) – to allow for the development and submission of new safety and effectiveness data. All manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products.

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  1. One must always exercise caution when using chemicals to promote health and well being. This is true even of antibacterial soaps. The same argument that is currently being made surrounding antibiotics can be applied to antibacterial soaps such as triclosan. These chemicals may be valuable in the short-term; however, overuse and abuse could lead to the development of resistance in targeted microbes. Studies have proven that microbes evolve at a faster rate when a stressor, such as an antibacterial, is applied. It is crucial that our use of antibiotics and antibacterials be monitored and frequently adjusted to account for bacterial resistance.
    Given that the FDA’s study has not shown any true benefits to using chemicals such as triclosan compared to soap and water, their decision to ban the chemicals is for the best. It is not worth risking a future epidemic caused by resistant bacteria to kill less than 0.1% more bacteria than leading soap brands.

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